NeoplasmsNCT07542925
Prediction of Postoperative ICU Requirement in Oncologic Surgery
An observational study of Neoplasms and Postoperative Complications, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to compare the performance of commonly used perioperative risk scoring systems in predicting postoperative intensive care unit (ICU) requirement among adult patients undergoing oncologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Postoperative Complications, Perioperative/Postoperative Complications
- What is being tested?
- Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 and older) who are scheduled to undergo elective or emergency oncologic surgery at a single tertiary oncology training and research hospital. The population includes patients with various types of cancer requiring surgical intervention, where postoperative intensive care unit (ICU) requirement needs to be predicted using clinical risk scoring systems.
Who may be able to join
- Patients aged 18 years and older.
- Patients scheduled for elective or emergency oncologic surgery.
- Patients who are able to provide written informed consent.
- Patients whose data will be analyzed for both planned and unplanned intensive care unit (ICU) admissions.
Who cannot join
- Patients under 18 years of age.
- Patients requiring continuous ICU follow-up due to a pre-existing critical illness prior to the current surgery.
- Patients who do not provide consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
Busra Uslu YAMAN
About this study
Official title: Comparison of ASA, SORT, CACI, and P-POSSUM Scores for Predicting Postoperative Intensive Care Unit Requirement in Patients Undergoing Oncologic Surgery
This prospective observational cohort study aims to compare the performance of commonly used perioperative risk scoring systems in predicting postoperative intensive care unit (ICU) requirement among adult patients undergoing oncologic surgery. Accurate prediction of postoperative ICU admission is essential for optimizing patient safety and efficient allocation of limited critical care resources, particularly in high-risk oncologic surgical populations.
A total of 500 adult patients scheduled for elective or emergency oncologic surgery will be prospectively enrolled at a single tertiary oncology center. Preoperative clinical and demographic data, intraoperative variables, and perioperative characteristics will be recorded using a standardized data collection form. Risk assessment will include the American Society of Anesthesiologists (ASA) Physical Status classification, Surgical Outcome Risk Tool (SORT), Age-adjusted Charlson Comorbidity Index (CACI), Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels.
The primary outcome is the need for postoperative ICU admission within the first 24 hours after surgery. Secondary outcomes include unplanned ICU admission, duration of ICU stay, need for mechanical ventilation, hospital length of stay, and 30-day mortality. The predictive performance of each scoring system will be evaluated using receiver operating characteristic (ROC) analysis and multivariable logistic regression models.
Read the detailed description
Postoperative intensive care unit (ICU) admission represents a critical component of perioperative management, particularly in patients undergoing oncologic surgery who frequently present with advanced age, multiple comorbidities, impaired functional capacity, and increased perioperative risk. Accurate preoperative identification of patients requiring postoperative critical care is essential to improve patient outcomes, optimize perioperative planning, and ensure appropriate allocation of limited ICU resources.
Several perioperative risk assessment tools are routinely used in clinical practice, including the American Society of Anesthesiologists (ASA) Physical Status classification, the Surgical Outcome Risk Tool (SORT), and the Age-adjusted Charlson Comorbidity Index (CACI). However, comparative prospective evidence regarding their ability to predict postoperative ICU requirement remains limited. The Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), which incorporates both physiological and operative variables, may provide additional prognostic value beyond traditional preoperative scoring systems. Furthermore, functional status and nutritional condition are increasingly recognized as important determinants of surgical outcomes in oncology patients. Therefore, inclusion of Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels may enhance predictive accuracy.
This study is designed as a single-center prospective observational cohort study enrolling adult patients undergoing elective or emergency oncologic surgery. Eligible patients aged 18 years or older will be consecutively included and followed throughout the perioperative period. Preoperative demographic and clinical characteristics, intraoperative variables, and perioperative management data will be recorded using a standardized data collection system.
The primary objective of the study is to evaluate and compare the predictive performance of ASA, SORT, CACI, P-POSSUM, ECOG performance status, and NRS-2002 scores for postoperative ICU requirement within the first 24 hours after surgery. Secondary objectives include assessment of unplanned ICU admission, mechanical ventilation requirement, ICU length of stay, hospital length of stay, and 30-day mortality.
Predictive performance will be evaluated using receiver operating characteristic (ROC) curve analysis with calculation of area under the curve (AUC) values. Differences between scoring systems will be assessed using appropriate statistical comparison methods, and multivariable logistic regression analysis will be performed to determine independent predictors of postoperative ICU requirement while adjusting for potential confounding variables.
The findings of this study are expected to support evidence-based perioperative risk stratification and contribute to improved clinical decision-making regarding postoperative critical care planning in oncologic surgical patients.
- Conditions
- Neoplasms, Postoperative Complications, Perioperative/Postoperative Complications, Intensive Care Units
- Being tested
- Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)
- Medical subject headings
- Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)Other
The study evaluates the predictive performance of various risk scoring systems for postoperative intensive care unit (ICU) requirement in adult patients undergoing oncologic surgery. Preoperative and intraoperative data will be collected to calculate ASA, SORT, CACI, P-POSSUM, ECOG, and NRS-2002 scores. The primary outcome is the need for ICU admission within the first 24 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Oncologic Surgery Patients | Adult patients (≥18 years) undergoing elective or emergency oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Receives: Other: Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Unplanned Postoperative ICU Admission
The number of participants with an unplanned admission to the ICU within the first 24 hours following oncological surgery.
Measured: Up to 24 hours post-surgery
Secondary outcomes (4)
30-Day All-Cause Mortality
All-cause mortality is defined as any death, regardless of cause, occurring within 30 days following surgery. Mortality data will be collected from hospital records and verified by follow-up (including telephone contact if required). Both in-hospital deaths and deaths occurring after discharge within the 30-day postoperative period will be included in the analysis.
Measured: Up to 30 days post-surgery
Duration of ICU Stay (in Days)
Total number of days spent in the intensive care unit from the date of ICU admission until the date of ICU discharge during the index hospitalization.
Measured: From date of ICU admission until the date of ICU discharge, assessed up to 30 days post-surgery.
Number of Participants Requiring Mechanical Ventilation within 24 Hours after Surgery
Mechanical ventilation requirement is defined as the need for invasive ventilatory support within the first 24 hours after surgery. Data will be obtained from anesthesia and postoperative care records.
Measured: Up to 24 hours post-surgery
Length of Hospital Stay (in Days)
Total number of days from hospital admission to official hospital discharge.
Measured: From the date of hospital admission until the date of hospital discharge, assessed up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Dec 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra USLU YAMAN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542925
- Sponsor's protocol ID
- 2025-12/193
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as stated in the ethical committee approval.
Publications
Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
PubMed 27428118Mukherjee S, Kedia A, Goswami J, Chakraborty A. Validity of P-POSSUM in adult cancer surgery (PACS). J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):61-65. doi: 10.4103/joacp.JOACP_128_20. Epub 2022 Apr 25.
PubMed 35706623Yildirim M, Halacli B, Kaya EK, Ulusoydan E, Ortac Ersoy E, Topeli A. Prognostic Accuracy of Nutritional Assessment Tools in Critically-Ill COVID-19 Patients. J Clin Med. 2025 May 13;14(10):3382. doi: 10.3390/jcm14103382.
PubMed 40429378
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ASA, SORT, CACI, and P-POSSUM Scores for Predicting Postoperative Intensive Care Unit Requirement in Patients Undergoing Oncologic Surgery
- ClinicalTrials.gov ID
- NCT07542925
- Acronym / sponsor ID
- 2025-12/193
- Conditions
- Neoplasms, Postoperative Complications, Perioperative/Postoperative Complications, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational cohort study aims to compare the performance of commonly used perioperative risk scoring systems in predicting postoperative intensive care unit (ICU) requirement among adult patients undergoing oncologic surgery. Accurate prediction of postoperative ICU admission is essential for optimizing patient safety and efficient allocation of limited critical care resources, particularly in high-risk oncologic surgical populations.
A total of 500 adult patients scheduled for elective or emergency oncologic surgery will be prospectively enrolled at a single tertiary oncology center. Preoperative clinical and demographic data, intraoperative variables, and perioperative characteristics will be recorded using a standardized data collection form. Risk assessment will include the American Society of Anesthesiologists (ASA) Physical Status classification, Surgical Outcome Risk Tool (SORT), Age-adjusted Charlson Comorbidity Index (CACI), Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels.
The primary outcome is the need for postoperative ICU admission within the first 24 hours after surgery. Secondary outcomes include unplanned ICU admission, duration of ICU stay, need for mechanical ventilation, hospital length of stay, and 30-day mortality. The predictive performance of each scoring system will be evaluated using receiver operating characteristic (ROC) analysis and multivariable logistic regression models.
Detailed description
Postoperative intensive care unit (ICU) admission represents a critical component of perioperative management, particularly in patients undergoing oncologic surgery who frequently present with advanced age, multiple comorbidities, impaired functional capacity, and increased perioperative risk. Accurate preoperative identification of patients requiring postoperative critical care is essential to improve patient outcomes, optimize perioperative planning, and ensure appropriate allocation of limited ICU resources.
Several perioperative risk assessment tools are routinely used in clinical practice, including the American Society of Anesthesiologists (ASA) Physical Status classification, the Surgical Outcome Risk Tool (SORT), and the Age-adjusted Charlson Comorbidity Index (CACI). However, comparative prospective evidence regarding their ability to predict postoperative ICU requirement remains limited. The Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and morbidity (P-POSSUM), which incorporates both physiological and operative variables, may provide additional prognostic value beyond traditional preoperative scoring systems. Furthermore, functional status and nutritional condition are increasingly recognized as important determinants of surgical outcomes in oncology patients. Therefore, inclusion of Eastern Cooperative Oncology Group (ECOG) performance status, Nutritional Risk Screening 2002 (NRS-2002), and preoperative serum albumin levels may enhance predictive accuracy.
This study is designed as a single-center prospective observational cohort study enrolling adult patients undergoing elective or emergency oncologic surgery. Eligible patients aged 18 years or older will be consecutively included and followed throughout the perioperative period. Preoperative demographic and clinical characteristics, intraoperative variables, and perioperative management data will be recorded using a standardized data collection system.
The primary objective of the study is to evaluate and compare the predictive performance of ASA, SORT, CACI, P-POSSUM, ECOG performance status, and NRS-2002 scores for postoperative ICU requirement within the first 24 hours after surgery. Secondary objectives include assessment of unplanned ICU admission, mechanical ventilation requirement, ICU length of stay, hospital length of stay, and 30-day mortality.
Predictive performance will be evaluated using receiver operating characteristic (ROC) curve analysis with calculation of area under the curve (AUC) values. Differences between scoring systems will be assessed using appropriate statistical comparison methods, and multivariable logistic regression analysis will be performed to determine independent predictors of postoperative ICU requirement while adjusting for potential confounding variables.
The findings of this study are expected to support evidence-based perioperative risk stratification and contribute to improved clinical decision-making regarding postoperative critical care planning in oncologic surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncologic Surgery Patients | – | Other: Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)Adult patients (≥18 years) undergoing elective or emergency oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 and older) who are scheduled to undergo elective or emergency oncologic surgery at a single tertiary oncology training and research hospital. The population includes patients with various types of cancer requiring surgical intervention, where postoperative intensive care unit (ICU) requirement needs to be predicted using clinical risk scoring systems.
Key inclusion criteria (4 listed)
- Patients aged 18 years and older.
- Patients scheduled for elective or emergency oncologic surgery.
- Patients who are able to provide written informed consent.
- Patients whose data will be analyzed for both planned and unplanned intensive care unit (ICU) admissions.
Key exclusion criteria (3 listed)
- Patients under 18 years of age.
- Patients requiring continuous ICU follow-up due to a pre-existing critical illness prior to the current surgery.
- Patients who do not provide consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Assessment Scoring Systems (ASA, SORT, CACI, P-POSSUM, ECOG, NRS-2002)The study evaluates the predictive performance of various risk scoring systems for postoperative intensive care unit (ICU) requirement in adult patients undergoing oncologic surgery. Preoperative and intraoperative data will be collected to calculate ASA, SORT, CACI, P-POSSUM, ECOG, and NRS-2002 scores. The primary outcome is the need for ICU admission within the first 24 hours postoperatively. | Other | Oncologic Surgery Patients |
Primary outcome
Incidence of Unplanned Postoperative ICU Admission
Time frame: Up to 24 hours post-surgery
The number of participants with an unplanned admission to the ICU within the first 24 hours following oncological surgery.
4 secondary outcomes
30-Day All-Cause Mortality
Time frame: Up to 30 days post-surgery
Duration of ICU Stay (in Days)
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days post-surgery.
Number of Participants Requiring Mechanical Ventilation within 24 Hours after Surgery
Time frame: Up to 24 hours post-surgery
Length of Hospital Stay (in Days)
Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 27428118Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
- Background: PubMed 35706623Mukherjee S, Kedia A, Goswami J, Chakraborty A. Validity of P-POSSUM in adult cancer surgery (PACS). J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):61-65. doi: 10.4103/joacp.JOACP_128_20. Epub 2022 Apr 25.
- Background: PubMed 40429378Yildirim M, Halacli B, Kaya EK, Ulusoydan E, Ortac Ersoy E, Topeli A. Prognostic Accuracy of Nutritional Assessment Tools in Critically-Ill COVID-19 Patients. J Clin Med. 2025 May 13;14(10):3382. doi: 10.3390/jcm14103382.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure patient confidentiality and data privacy, as stated in the ethical committee approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Postoperative Complications, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Busra Uslu YAMAN (+905068321017, buslu.1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Unplanned Postoperative ICU Admission (time frame: Up to 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07542925, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.